Evaluation of the Efficiency of Propioceptive Study According to Radiological Stages in Patients With Knee Osteoarthritis

July 7, 2024 updated by: Sibel Gayretli Atan, Istanbul University
Evaluation of the Efficiency of Propioceptive Study According to Radiological Stages in Patients with Knee Osteoarthritis

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Investigators divided patients with knee osteoarthritis into two groups. Group 1 consisted of stage 1 and stage 2 patients. Group 2 consisted of stage 3 and stage 4 patients. Proprioceptive training was applied in both groups. Investigators aim is to evaluate the effect of proprioceptive exercises on knee osteoarthritis according to the radiological level.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Istanbul
      • Uskudar, Istanbul, Turkey, 34668
        • Istanbul Health Sciences University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with knee osteoarthritis by a specialist physician using MRI, US or radiography and physical examination.
  • Being between the ages of 35-70
  • Stage 1-2-3-4 according to Kellegran Lawrence (K-L) in radiological examination

Exclusion Criteria:

Having active synovitis

  • Having received physical therapy in the last 6 months
  • Those with neurological problems that affect walking
  • Those with serious respiratory, central, peripheral, vascular and uncontrolled metabolic problems that will prevent exercise
  • Has had lower extremity surgery in the past
  • Intra-articular steroid injections within the last 6 months
  • Using psychoactive drugs
  • Those with serious vision, hearing and speech disorders
  • Patients with vestibular dysfunction will not be included in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1
This group includes patients with grade 1 and grade 2 knee osteoarthritis.
Other: Proprioceptive training
Proprioceptive exercises were applied to both groups. In addition to these exercises, balance, coordination and strengthening exercises will also be applied to both groups.
Experimental: Group 2
This group includes patients with grade 3 and grade 4 osteoarthritis.
Other: Proprioceptive training
Proprioceptive exercises were applied to both groups. In addition to these exercises, balance, coordination and strengthening exercises will also be applied to both groups.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame: Evaluation will be performed before treatment and after 4 weeks rehabilitation program.
The scale consists of 3 main headings and 24 questions. It is scored between 0 and 100. There is a negative correlation between scoring and functionality.
Evaluation will be performed before treatment and after 4 weeks rehabilitation program.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proprioception Sense
Time Frame: Evaluation will be performed at Baseline (before treatment) and 4 weeks
The sense of proprioception will be measured using a digital goniometer. It will be repeated 3 times. The average will be recorded
Evaluation will be performed at Baseline (before treatment) and 4 weeks
Visual Analogue Scale (VAS)
Time Frame: Evaluation will be performed at Baseline (before treatment) and 4 weeks
The levels of pain is felted at rest / activity / night will be measured using Visual Analogue Scale (VAS)..Patients will be asked to evaluate their pain status with a 10-point scale and high scores are positively correlated with pain
Evaluation will be performed at Baseline (before treatment) and 4 weeks
Pressure Pain Threshold Measurement
Time Frame: Evaluation will be performed at Baseline (before treatment) and 4 weeks
A digital algometer will be used for Pressure Pain Threshold Measurement. Digital algometer is a device that objectively evaluates the pressure pain threshold. Low values indicate increased sensitivity and pain sensation.
Evaluation will be performed at Baseline (before treatment) and 4 weeks
Range of Motion (ROM)
Time Frame: Evaluation will be performed at Baseline (before treatment) and 4 weeks
Knee,food and hip ROM will be evaluated with digital goniometer while the patient will be in supine and prone position.
Evaluation will be performed at Baseline (before treatment) and 4 weeks
Timed Up and Go Test (TUG)
Time Frame: Evaluation will be performed at Baseline (before treatment) and 4 weeks
The scale consists of 7 questions measuring the physical activity of the individual in the last 7 days. The activity level is determined according to the scale score.
Evaluation will be performed at Baseline (before treatment) and 4 weeks
Manual Muscle Test
Time Frame: Evaluation will be performed at Baseline (before treatment) and 4 weeks
Manual Muscle Test is a procedure for the evaluation of strength of individual muscle or muscles group, based upon the effective performance of a movement in relation to the forces of gravity or manual resistance through the available ROM.
Evaluation will be performed at Baseline (before treatment) and 4 weeks
Short Form 36 (SF-36)
Time Frame: Evaluation will be performed at Baseline (before treatment) and 4 weeks
SF-36 will be used to assess physical and mental health-related quality of life. The total score is at least 0 and at most 100, and the high scores are positively correlated with high quality of life.
Evaluation will be performed at Baseline (before treatment) and 4 weeks
Global Rating of Change (GRC) Scale
Time Frame: 4 weeks
Global Rating of Change (GRC) scale will be used to assess the overall satisfaction levels of the patients. Patients will be asked to evaluate their post-treatment status with a 5-point likert scale and high scores are positively correlated with satisfaction.
4 weeks
International Physical Activity Scale (IPAQ)
Time Frame: Evaluation will be performed at Baseline (before treatment) and 4 weeks
The scale consists of 7 questions measuring the physical activity of the individual in the last 7 days. The activity level is determined according to the scale score.
Evaluation will be performed at Baseline (before treatment) and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sibel Gayretli Atan, sssibel_38@hotmail.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 21, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 21, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SBU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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